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The European Medicines Agency (EMA) has warned that the capillary leak syndrome (CLS) should be added as new side effect to the labeling of the AstraZeneca coronavirus vaccine.
“The EMA safety committee concluded that people who previously have had capillary leak syndrome must not be vaccinated with Vaxzevria (formerly COVID-19 AstraZeneca vaccine), “the entity said in a statement.
In addition, he clarified that capillary leak syndrome “should be added to the product information as a new side effect of the vaccine, with a Warning make healthcare professionals and patients aware of this risk. “
“Capillary Leak Syndrome is a very rare serious disease that causes loss of fluid from small blood vessels (capillaries), which causes swelling mainly in the arms and legs, low blood pressure, thickening of the blood and low levels of albumin in the blood, ”described the EMA.
The Committee reviewed the six cases of capillary leak syndrome in people who received the vaccine, “the majority of cases have occurred in women and within 4 days of vaccination,” the EMA reported.
“Three of those affected had a history of capillary leak syndrome and one of them deceased later ”, underlined the European organization.
The EMA clarified that capillary leak syndrome “should be added to the product information as a possible side effect. FotoReuter.
It is a new, extremely rare side effect is added to the thromboembolism. In April, the EMA concluded an investigation and said there was a “possible link” between the AstraZeneca vaccine and cases of unusual blood clotting detected weeks after the injection. She therefore decided to include this clinical picture among the side effects. very rare of this vaccine.
However, the EMA did not define any specific risk factors, such as age, gender, or specific medical history, and maintained its positive assessment between benefits and risks vaccination with AstraZeneca, since it prevents hospitalizations and deaths in people infected with covid-19.
According to official data, as of May 27, more than 78 million doses AstraZeneca vaccine in the UK and the European Economic Area (EEA), which includes the 27 countries of the European Union (EU), as well as Iceland, Liechtenstein and Norway.
On the other hand, the EMA urged pharmaceutical companies and healthcare professionals to report on case of myocarditis or pericarditis in patients who have received one of the COVID-19 vaccines authorized in the EU, to complete an ongoing assessment of its possible relationship between the formula and these inflammations.
According to the European Medicines Agency, it continues to assess, since last April, “reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane that surrounds the heart) reported in a small number of people” received one or two doses of Pfizer / BioNTech, Moderna, AstraZeneca or Janssen.
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